FDA (Drugs) recall action 83792
The FDA (Drugs) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.
Defective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Shire is recalling Natpara (parathyroid hormone) injection cartridges because rubber stopper particles may clog the needle, leading to underdosing.
Shire is recalling Natpara (parathyroid hormone) for Injection due to a defective delivery system that may allow rubber stopper particles to clog the needle, leading to underdosing.
Shire is recalling Natpara (parathyroid hormone) injections because rubber stopper particles may clog the needle, potentially causing underdosing.
Shire is recalling Natpara injection cartridges because rubber stopper particles may clog the needle, potentially causing underdosing.